PHARMACEUTICAL COMPOSITIONS OF FINGOLIMOD

The present invention relates to a pharmaceutical composition comprising fingolimod, a pharmaceutically acceptable salt thereof or a phosphate derivative, having less than about 0.5% concentration (w/w) of Impurity I after six months stability study at 40°C and 75% RH. La présente invention concerne...

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Main Authors THUMMISETTY, MASTANAIAH, RUDRARAJU, VARMA S, ALLURI, PAVAN KUMAR, MYLAMALA, SUBHASH CHANDRA BOSE, KANDARAPU, RAGHUPATHI
Format Patent
LanguageEnglish
French
Published 24.03.2016
Subjects
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Summary:The present invention relates to a pharmaceutical composition comprising fingolimod, a pharmaceutically acceptable salt thereof or a phosphate derivative, having less than about 0.5% concentration (w/w) of Impurity I after six months stability study at 40°C and 75% RH. La présente invention concerne une composition pharmaceutique comprenant le fingolimod, un sel pharmaceutiquement acceptable de celui-ci ou un dérivé de phosphate dont la concentration en impuretés I (w/w) est inférieure à environ 0,5 % au bout de six mois d'étude de stabilité à 40 °C et pour 75 % d'humidité relative (RH).
Bibliography:Application Number: WO2015IB57123